Quality & Compliance: Characterization of Risks, Research Subjects and the Regulatory Professional

Posted 01 June 2008 | By

The first article in this series1 examined the EMEA guideline2 issued following the injury of healthy volunteers in the TeGenero first-in-man clinical trial, while the second article3 explored some of the lessons learned from the study. Part three explores the concept of risk as it relates to research subjects. This article looks at the roles of the research subject and the regulatory professional in first-inman phase 1 studies for novel compounds and those that could be classified as relatively high risk.


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